Transcranial Focused Ultrasound for Depression and Anxiety

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neurological Associates of West Los Angeles

Disqualifiers: Pregnancy, Active cancer, Advanced organ failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores transcranial focused ultrasound, a non-invasive treatment, for individuals with difficult-to-treat depression and anxiety. Researchers aim to determine if this method is safe over time and if it alleviates symptoms for those unresponsive to other medications. Suitable candidates have either major depressive disorder or generalized anxiety disorder that hasn't improved with at least three different medications. As an unphased trial, participants can contribute to pioneering research that may lead to new treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves patients who have not improved with three antidepressants or anxiolytics, it might be possible to continue your current treatment. Please consult with the trial coordinators for specific guidance.

What prior data suggests that transcranial focused ultrasound is safe for treating depression and anxiety?

Research shows that the safety of transcranial focused ultrasound (tFUS) remains under investigation. tFUS is a non-invasive method, meaning it doesn't involve surgery. However, its safety and effectiveness as a treatment are not yet fully understood. Some studies have explored its use for conditions like major depressive disorder, but clear safety information remains limited. This lack of detailed safety data indicates that more research is needed to assess how well people tolerate this treatment. Prospective clinical trial participants should know that this treatment is still in the early testing stages. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Focused Ultrasound (TFUS) is unique because it offers a non-invasive way to target specific areas of the brain associated with depression and anxiety. Unlike traditional treatments like medication or therapy, which can take weeks to show effects, TFUS has the potential to deliver quicker results by directly influencing brain activity. Researchers are excited about TFUS because it avoids the side effects often seen with drugs and provides a completely different mechanism by using sound waves to stimulate or disrupt neural pathways, potentially leading to more precise and effective management of symptoms.

What evidence suggests that transcranial focused ultrasound is effective for depression and anxiety?

Research shows that transcranial focused ultrasound (tFUS) is under investigation as a potential treatment for major depressive disorder. Studies have found that tFUS can safely target specific brain areas without surgery. This method uses sound waves to stimulate brain regions involved in mood control. Early results suggest it might benefit those who haven't improved with other treatments. While it appears safe and practical, further research is needed to confirm its effectiveness for depression and anxiety. ^{1 2 3 4 6}

Who Is on the Research Team?

Sheldon Jordan, MD

Principal Investigator

Neurological Associates - the Interventional Group

Are You a Good Fit for This Trial?

This trial is for adults who have tried at least three antidepressants and anxiolytics without improvement, have a diagnosis of Major Depressive Disorder or Generalized/Acute Anxiety Disorder, and score high on anxiety and depression scales.

Inclusion Criteria

You have a score of more than 13 on a test called the Beck Depression Inventory.

I have tried 3 different anxiety medications without success.

I have tried 3 antidepressants without success.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial focused ultrasound treatment for depression and anxiety

8 weeks

8 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Focused Ultrasound

Trial Overview The study is testing the use of transcranial focused ultrasound as a treatment. It's an open label study, meaning everyone knows they're getting the treatment, to see if it helps with severe depression and anxiety.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

All patients enrolled will receive transcranial focused ultrasound. Target location is dependent on patient condition.

Who Is Running the Clinical Trial?

Neurological Associates of West Los Angeles

Lead Sponsor

Trials

26

Recruited

4,000+

Published Research Related to This Trial

Low-intensity focused ultrasound (LIFU) is a promising noninvasive technique for neuromodulation that could improve treatment outcomes for patients with Major Depressive Disorder (MDD) and Obsessive-Compulsive Disorder (OCD) who do not respond to traditional therapies.

Current psychosurgical techniques, such as deep-brain stimulation, have variable success rates, with only about half of patients showing adequate response, highlighting the need for innovative approaches like LIFU to enhance personalized treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Definition of Surgical Targets in Major Depression and Obsessive-Compulsive Disorder: A Potential Role for Low-Intensity Focused Ultrasound? Guinjoan, SM.[2023]

Transcranial focused ultrasound (tFUS) is a promising non-surgical technique for neuromodulation that offers better spatial resolution compared to traditional electro and electromagnetic methods.

tFUS can effectively target sub-cortical brain structures non-invasively, and its combination with BOLD functional MRI allows for enhanced examination of brain activity in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial focused ultrasound for BOLD fMRI signal modulation in humans. Leo Ai, ., Mueller, JK., Grant, A., et al.[2022]

The dual-crossed transducer system achieved high spatial resolution in targeting small brain regions in mice, with a focal volume of under 0.52 μm³ and a focal diameter of 1 mm, making it effective for precise neuromodulation.

In vivo experiments demonstrated successful brain stimulation in wild-type mice, evidenced by observable movements, confirming the system's capability for noninvasive and specific targeting of brain circuits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial focused ultrasound stimulation with high spatial resolution. Kim, S., Jo, Y., Kook, G., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11321877/

Effect of Low-Intensity Transcranial Focused Ultrasound ... The present study aimed to investigate the safety and effectiveness of low-intensity tFUS in treating major depressive disorder.

2. nature.com nature.com/articles/s41380-025-03033-w

Low-intensity transcranial focused ultrasound amygdala ... tFUS is a non-invasive technique for direct subcortical neuromodulation, but its safety, feasibility, and promise as a potential treatment is largely unknown.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40275098/

a double-blind sham-controlled target engagement study and ... tFUS is a non-invasive technique for direct subcortical neuromodulation, but its safety, feasibility, and promise as a potential treatment is largely unknown.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1094715924006627

A Comprehensive Review of Low-Intensity Focused ... Low-intensity focused ultrasound (LIFU) is gaining increased interest as a potential therapeutic modality for a range of neuropsychiatric diseases.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07108257

Magnetic Resonance-Guided Focused Ultrasound Bilateral ... The goal of this clinical trial is to evaluate the safety and initial effectiveness of MR-guided focused ultrasound (MRgFUS) bilateral capsulotomy in patients ...

6. fusfoundation.org fusfoundation.org/for-researchers-and-clinicians/foundation-funded-research-projects/

Foundation Funded Research Projects Will FUS be safe and effective in treating patients with brain tumors? A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused ...